Promising results with osimertinib for EGFR-NSCLC with LMs

  • Yang JCH & al.
  • J Clin Oncol
  • 6 Dec 2019

  • curated by Kelli Whitlock Burton
  • Univadis Clinical Summaries
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Takeaway

  • Osimertinib yielded good objective response rates (ORRs), with promising PFS, in previously treated epidermal growth factor receptor-mutated (EGFRm) NSCLC and leptomeningeal metastases (LMs).

Why this matters

  • There are currently no standardized therapies for EGFRm NSCLC with LMs.

Study design

  • Open-label, multicenter, phase 1 trial.
  • 41 patients with EGFR-mutated NSCLC and LMs previously treated with EGFR tyrosine kinase inhibitors received 160 mg osimertinib once daily.
  • Median follow-up, 9.9 months.
  • Funding: AstraZeneca.

Key results

  • Clinically meaningful LM ORR was recorded, but the ORR was higher by neuroradiologic-blinded central independent review (BICR) than by investigator (62% vs 27%).
  • Stable disease rate was also clinically relevant, but differed by reviewers (61% by investigator vs 32% by BICR).
  • Median LM duration of response was 15.2 months by BICR and 18.9 months by investigator.
  • Neurological function improved in 57% of patients with abnormal neurologic function at baseline.
  • Median investigator-assessed PFS was 8.6 months, with 42% of patients progression free at 12 months.
  • Tolerability profile was similar to that in previous studies of osimertinib.
  • 66% of patients had grade ≥3 AEs.

Limitations

  • Discrepancies in BICR and investigator results.